- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353249
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women
Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Exposure to traumatic events may lead to mental health problems, such as post-traumatic stress disorder (PTSD). PTSD is a type of anxiety disorder that is characterized by the presence of persistent frightening thoughts and memories of the traumatic event. Additionally, people with PTSD often feel emotionally numb, and they may experience sleep problems or be easily startled. Homeless people, in particular, are at risk for experiencing a variety of traumas. Homeless women tend to experience more traumatic events and develop PTSD at higher rates than housed women. Although effective treatments for PTSD are available, homeless women are unlikely to seek them out. There is a need for PTSD treatment approaches that are specifically designed for these women. This study will develop a cognitive-behavioral therapy treatment that will be adapted to best serve the needs of homeless women. The study will then determine the therapy's effectiveness in treating a group of homeless women with PTSD.
This study will consist of three phases. The first phase will be used to gather and analyze information about PTSD in homeless women and methods of treating the disorder in this population. Focus groups consisting of homeless women, shelter directors, case managers, and mental health service providers will be used to obtain the necessary information. Phase two of this study will consist of developing an adaptation of an existing PTSD treatment manual to make it relevant to the lives of homeless women. The third and final phase of this study will recruit 32 homeless women with symptoms of PTSD, and who did not participate in either of the first two phases of the study. Participants in this 4-week study will be randomly assigned to receive either the adapted cognitive behavioral therapy treatment or no treatment at all (assessment-only). The treatment group will attend twice weekly sessions for a total of 4 weeks. All participants will be evaluated immediately prior to the start of treatment and 1 week after treatment ends. Outcomes will include PTSD symptoms and depression symptoms.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles County, California, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sub-diagnostic threshold PTSD symptoms
- Currently resides in a transitional homeless shelter in Los Angeles County
- Trauma that is related to PTSD symptoms occurred at least 1 month prior to study entry
- Understands, speaks, and reads English
- Planned departure date from the shelter is at least 1 month after study entry
Exclusion Criteria:
- Significant cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will receive adapted cognitive behavioral therapy treatment
|
Adapted CBT is a group treatment for PTSD and will occur two times per week for 4 weeks.
The sessions will last 90-minutes and will be led by a therapist and co-therapist.
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No Intervention: 2
Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PTSD symptoms
Time Frame: Measured at Week 4
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Measured at Week 4
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Depression symptoms
Time Frame: Measured at Week 4
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Measured at Week 4
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne Wenzel, PhD, RAND
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH076099 (U.S. NIH Grant/Contract)
- DSIR 82-SEMS (Other Identifier: National Institute of Mental Health)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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